Phase II Study of Irinotecan Plus Capecitabine as the First-line or Second-line Treatment for Advanced Colorectal Cancer Patients

Fudan University1 site in 1 country52 target enrollmentMarch 2011

ConditionsColorectal Cancer

Interventionsirinotecan, capecitabine

Drugsirinotecan, capecitabine

Overview

Phase: Phase 2
Intervention: irinotecan, capecitabine
Conditions: Colorectal Cancer
Sponsor: Fudan University
Enrollment: 52
Locations: 1
Primary Endpoint: Rate of Diarrhea
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objectives of this study are to evaluate the efficacy and tolerability of single-week regimen of irinotecan plus capecitabine in the first-line or second-line treatment of advanced colorectal cancer.

Detailed Description

Irinotecan and capecitabine are approved to be the effective drugs for the advanced colorectal cancer patients. However, the combination of these two drugs are not regularly recommended due to the severe diarrhea as the most common adverse event.This study was designed to explore whether the single-week regimen of irinotecan plus capecitabine improves efficacy and does not increase the toxicity in advanced colorectal cancer patients in China.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

June 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Jin Li

Fudan University

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•Histologically confirmed colorectal cancer
•Age 18-70 years old
•Advanced colorectal cancer patients, first-line or second-line treatment, the adjuvant treatment including the oxaliplatin or/and 5FU should be finished six months before
•Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
•Life expectancy of more than 3 months.
•Normal laboratory values: hemoglobin \> 90g/dl, neutrophils \> 1.5×10\^9/L, platelets \> 100×10\^9/L, serum creatinine \< 1.5×upper limit of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN, AKP \< 4×ULN

Exclusion Criteria

•Pregnant or lactating patients
•Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
•Active or uncontrolled infection
•Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
•Patients could not swallow the tablets
•Concomitant with brain metastases

Arms & Interventions

wXELIRI regimen

Intervention: irinotecan, capecitabine

Outcomes

Primary Outcomes

Rate of Diarrhea

Time Frame: eight weeks

Secondary Outcomes

Progression free survival(eight weeks)
Response rate(eight weeks)
Disease control rate(eight weeks)
Overall survival(eight weeks)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability(eight weeks)